Early detection and prevention of symptomatic post-surgical hypoparathyroidism after thyroid surgery
PRESS -PAR: Early Detection and PREvention of Symptomatic postSurgical hypoPARathyroidism After Thyroid Surgery"
This project tests whether measuring parathyroid hormone earlier after thyroid surgery and starting calcium plus active vitamin D when needed can reduce how many patients develop symptoms from low parathyroid function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 336 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Wuerzburg Academic / other |
| Locations | 1 site (Würzburg, Bavaria) |
| Trial ID | NCT07491601 on ClinicalTrials.gov |
What this trial studies
This interventional study enrolls adults undergoing total or bilateral thyroidectomy and performs early perioperative measurements of parathyroid hormone, calcium, and vitamin D, using an algorithm to guide prompt calcium and active vitamin D supplementation when indicated. Baseline data and patient-reported outcomes (SF-36, STAI-G, HPQ28, and a modified HPES symptom scale) are collected, with postoperative clinical visits on days 0, 1, and 2 and a planned six-month follow-up. Recruitment is planned over three years at the University Hospital Wuerzburg and excludes patients with preexisting parathyroid disease, prior neck surgery, pregnancy or breastfeeding, or inability to attend visits. The goal is to create a clear perioperative management algorithm to reduce symptomatic hypoparathyroidism, improve quality of life, and potentially shorten hospital stays.
Who should consider this trial
Good fit: Adults aged 18 or older undergoing total or bilateral thyroidectomy who can give informed consent and do not have preexisting parathyroid disease or prior neck surgery are ideal candidates.
Not a fit: Patients with existing parathyroid disorders, prior neck surgery, pregnant or breastfeeding individuals, or those unable to attend required perioperative visits are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce symptomatic hypoparathyroidism after thyroidectomy, improve patients' quality of life, and shorten hospital stays.
How similar studies have performed: Previous PTH-guided supplementation protocols have shown reductions in symptomatic hypocalcemia in several studies, though methods and patient selection have varied and large confirmatory trials are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Thyroidectomy or bilateral thyroid resection of any indication * Written informed consent obtained after detailed patient information and provision of an information sheet Exclusion Criteria: * Age ≤ 18 years * Concomitant parathyroid disease (primary or secondary hyperparathyroidism, pre-existing hypoparathyroidism of any cause) * Previous surgery in the neck region * Pregnancy or breastfeeding * Inability to attend study visits * Participation in another study that interferes with the endpoints * Missing or inadequate patient information
Where this trial is running
Würzburg, Bavaria
- Dept. Surgery I; University Hospital Wuerzburg — Würzburg, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Nicolas Schlegel, Prof. Dr. (MD) — Wuerzburg University Hospital
- Study coordinator: Nicolas Schlegel, Prof. Dr. (MD)
- Email: SCHLEGEL_N@ukw.de
- Phone: +49 931 201 38217
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.